Skip to content

The DEFinition of IroN dEficiency in chronic Heart Failure (DEFINE-HF) study

The DEFinition of IroN dEficiency in chronic Heart Failure (DEFINE-HF) study - Iron deficiency in heart failure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36894
Enrollment
120
Registered
2012-10-01
Start date
2013-09-09
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure and iron deficiency

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For all participants: 1. Patients 18 years or older. 2. Able to understand the procedures and are willing to provide informed consent.;For cardiac patients: 1. Accepted and scheduled for cardiothoracic surgery (coronary artery bypass graft surgery) at the Department for Cardiothoracic Surgery. 2. A known LVEF, either assessed by echocardiography, MUGA-scan or MRI-scan. If LVEF 125 pg/mL. ;For non-cardiac patients: 1. Accepted and scheduled for total hip/knee replacement at the Department for Orthopedic Surgery. 2. No manifestations of diabetes and with

Exclusion criteria

Exclusion criteria: 1. Patients younger than 18 years of age. 2. An unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation). 3. History of acquired iron overload 4. Severe concomitant renal failure (eGFR

Design outcomes

Primary

MeasureTime frame
Main study parameter/endpoint * Sensitivity and specificity (percentages) of possible novel serum markers reflecting iron status compared to BM iron staining.

Secondary

MeasureTime frame
Differences between iron deficient and non-iron deficient patients and between patients with and without HF: 1. Baseline characteristics (e.g. age, sex, NYHA class, medical history). 2. Right and left ventricular systolic and diastolic function. 3. Blood and urine markers (e.g. hemoglobin, inflammation, renal function, N-terminal pro-brain-type natriuretic peptide). 4. Rate and severity of eryptosis (e.g. more cell shrinkage). 5. Vital status/hospitalisations.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)